MAUDE Adverse Event Report: BECTON DICKINSON BD DISCARDIT¿ II - 2-PIECE SYRINGE; PISTON SYRINGE

Catalog Number 301866

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is bawal, india.This site is not registered with the fda.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.E1: enter address information: (b)(6).

Event Description

It was reported that 289 of the bd discardit¿ ii - 2-piece syringe experienced scale marking issues.1 of 2.The following information was provided by the initial reporter: marking defects.

Manufacturer Narrative

H6: investigation summary: photos were received by bd for evaluation.A quality engineer was able to review the photo for the reported complaints of marking defect, without syringe from lot number 2061254 regarding material number 301866.The photographs confirmed the reported defects on the syringe.The investigating team has used the retention samples of lot number 2061254 regarding material number 301866 for investigating the reported defect.The samples were visually tested, and no defect was found in the retention samples.The exact root cause can only be determined if we receive the original sample.H3 other text : see h10.

Event Description

It was reported that 289 of the bd discardit¿ ii - 2-piece syringe experienced scale marking issues.1 of 2.The following information was provided by the initial reporter: marking defects.

• Brand Name: BD DISCARDIT¿ II - 2-PIECE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16832596
• MDR Text Key: 314186692
• Report Number: 2243072-2023-00666
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301866
• Device Lot Number: 2061254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1